This study reports the first successful clinical application of a robotic-assisted system in transcatheter balloon-expandable aortic valve implantation using the Edwards SAPIEN 3 valve. Two male patients, aged 60 and 63 years, respectively, presented with severe aortic stenosis confirmed by echocardiography and computed tomography, showing significant valvular calcification and elevated transvalvular pressure gradients, meeting the indications for transcatheter aortic valve implantation (TAVI). Both procedures were performed via the right femoral artery using a robotic-assisted delivery and positioning system developed by Shanghai Surgerii Medical Technology Co., Ltd. The operator controlled the delivery system and valve positioning precisely through the console, while the assistant performed balloon expansion and valve deployment. Both procedures were completed successfully without intraoperative complications. The operative times were 75 minutes and 67 minutes, with fluoroscopy times of 16 minutes and 23 minutes, and radiation doses of 714 mGy and 971 mGy, respectively. Postoperative echocardiography demonstrated well-functioning prosthetic valves, with mean transvalvular pressure gradients of 3.9 mm Hg and 8.0 mm Hg, and none or trivial paravalvular leakage. No coronary obstruction, conduction disturbance, or vascular complications were observed. This report represents the world’s first clinical use of a robotic-assisted system for balloon-expandable TAVI. It confirms the feasibility and safety of robotic assistance in transcatheter valve delivery and positioning, offering a new approach to enhance procedural precision and stability, and providing valuable insights for the future development of intelligent, minimally invasive therapies for structural heart disease.
Transcatheter aortic valve replacement (TAVR) for aortic stenosis has been confirmed to be safe and efficient, and its status has gradually increased with the continuous updating of guidelines. But for severe pure aortic valve regurgitation, it has long been considered a relative contraindication to TAVR. However, many elderly, high-risk patients with pure aortic regurgitation have also been treated with TAVR and prognosis was improved through off-label use of transcatheter heart valves due to contraindications to surgery or intolerance. But because of the complexity and challenging anatomic features, high technical requirements, limited device success rate, high rate of complications, and lack of randomized controlled studies to confirm its safety and efficacy, TAVR treatment of pure aortic regurgitation has been evolving in a debate. In recent years, with the application of new-generation valves and an increasing number of studies, some new insights have been gained regarding TAVR for severe aortic regurgitation, and this article will review the progress of research on TAVR for severe pure aortic regurgitation.
In the present study, the performance of the liquid nitrogen frozen and thinned bovine pericardium was studied and compared with the porcine pericardium. The microstructure and mechanical properties of the bovine pericardium were observed and tested by hematoxylin-eosin (HE) staining and tensile test respectively. In all conditions, porcine pericardium was selected as a control group. The results showed that there was little difference in the performance of bovine pericardium after being frozen by liquid nitrogen. The secant modulus and ultimate strength of the thinned bovine pericardium were similar to those of porcine pericardium, however, the elastic modulus was a little higher than porcine pericardium. The study suggested that the performance of the thinned bovine pericardium was similar to those of porcine pericardium. It was easy for the thinned bovine pericardium to obtain a relatively ideal thickness and expected performance, therefore, the thinned bovine pericardium can be used as the materials of transcatheter aortic valve leaflets.
Transcatheter aortic valve replacement (TAVR) is effective in the treatment of severe symptomatic aortic stenosis and its applicable population is also gradually expanding, but it carries risk of ischemic and bleeding events, which underscores the importance of optimizing adjuvant antithrombotic regimens. The release of the 2022 version of Chinese expert consensus on antithrombotic therapy after transcatheter aortic valve implantation has promoted the standardized and safe development of antithrombotic therapy after TAVR in China. Combined with the latest progress of antithrombotic therapy after TAVR, from emphasizing ischemia and bleeding risk assessment, single-agent antiplatelet therapy for patients without anticoagulation indications, the selection of antithrombotic strategies for patients with other antithrombotic indications, antithrombotic strategy changes in postoperative valve thrombosis and bleeding events, this article interprets this consensus.
Objective To analyze the clinical intervention effect of multi-disciplinary team (MDT) nursing mode on patients after transcatheter aortic valve implantation (TAVI). Methods A total of 89 patients who were admitted to our hospital and underwent TAVI surgery from April to December 2021 were selected, including 64 males and 25 females, with an average age of 64.7±11.8 years. The subjects were divided into a MDT intervention group (n=42) and a control group (n=47) according to different postoperative nursing intervention methods. Clinical effectivenesses were compared between the two groups. Results The left ventricular ejection fraction in the two groups significantly increased on the 7th day after the operation, and the increase in the MDT intervention group was more obvious, with no statistical difference between the two groups (P=0.14). On the 7th day after surgery, forced vital capacity/predicated value and forced expiratory volume in one second/predicated value significantly decreased, and decreased more significantly in the control group than those in the MDT intervention group with statistical differences (P=0.01). The ICU stay time (P=0.01), hospital stay time (P<0.01) and total postoperative pulmonary complications rate (P=0.03) in the MDT intervention group were significantly shorter or lower than those in the control group The evaluation results of the anxiety and depression status of the patients before and after nursing intervention showed that the scores of anxiety and depression in the two groups were significantly lower than before, and the scores of each scale in the MDT intervention group were lower. The score of quality of life of the two groups significantly improved at the end of 6 months after surgery, and in the MDT intervention group it was significantly higher than that in the control group (P=0.02). Conclusion MDT intervention mode can promote the rapid recovery of patients after TAVI, effectively reduce the risk of postoperative pulmonary complications, and improve the postoperative quality of life.
For patients with aortic valve disease who require replacement of their native valve, surgical aortic valve replacement (SAVR) has been the standard of care. Due to the hemorrhage and thromboembolic risks of long-term anticoagulation therapy for mechanical prosthesis, bioprosthetic aortic valve replacement (AVR) has a trend to be used in younger patients, which raising the concern for the durability of bioprosthetic valves. The newly published 5-year outcomes of PERIGON trial, with no structural valve deterioration, again demonstrated the favorable durability of the new generation bioprosthetic valves, further providing the evidence of using bioprosthetic AVR in younger patients. At the meantime, the rapid progress of transcatheter aortic valve implantation (TAVI) has brought a new treatment option. For younger patients with low risks, choosing SAVR or TAVI becomes a critical decision. This paper reviews the outcomes of PERIGON trial and its implications to the clinical practice and research of bioprosthetic AVR.
Transcatheter aortic valve replacement (TAVR) has become the preferred treatment for severe aortic stenosis. The localization and anchor of many transcatheter heart valves available in the clinic today are dependent on the calcific aortic valve leaflet of patients. We reported here a successful case of transapical aortic valve implantation with Ken-Valve heart valve in an 82-year-old male patient with pure severe aortic regurgitation without native valve calcium. Postoperative follow-up (3 months after the surgery) showed that the cardiac function significantly improved. The echocardiography indicated that the Ken-Valve prosthesis worked well without perivalvular regurgitation. The short-term clinical effect was satisfactory. The Ken-Valve with three position anchors is proved to be suitable for the treatment of pure aortic regurgitation.
Objective To report our experience with enhanced recovery after surgery (ERAS) protocol in patients undergoing transapical transcatheter aortic valve implantation (TAVI) and to determine perioperative predictors for ERAS failure. Methods Between May 2018 and January 2019, 80 patients undergoing TAVI in our hospital were recruited. Among them, 40 patients (24 males, 16 females, aged 73.0±5.0 years) successfully received ERAS, defined as successful extubation in operating room (an ERAS group) and the other 40 patients (28 males, 12 females, aged 73.0±7.0 years, a non-ERAS group) failed to perform ERAS. Results Compared with the non-ERAS group, patients in the ERAS group were associated with a significantly lower incidence of postoperative complications (30.0% vs. 52.5%, P=0.04), shorter postoperative ICU stay (2.2±0.4 d vs. 4.0±4.8 d, P=0.00) and hospital stay (7.0±2.3 d vs. 9.5±4.8 d, P=0.00), and less medical cost (311±20 thousand yuan vs. 347±80 thousand yuan, P=0.00). Independent predictors of ERAS failure were poor preoperative heart function and elevated B-type natriuretic peptides. Conclusion ERAS protocol is feasible and effective in patients undergoing TAVI. Poor preoperative heart function is an independent predictor of failure in early extubation which, in turn, is associated with prolonged ICU and hospital stay and dramatic worsening of patient outcomes.
ObjectiveTo assess outcomes of transcatheter aortic valve replacement (TAVR) for pure native aortic valve regurgitation.MethodsA total of 129 patients underwent transfemoral TAVR in Fuwai Hospital from May 2019 to October 2020 were retrospectively analyzed. There were 83 males and 46 females with an average age of 72.26±8.97 years. The patients were divided into a pure native aortic valve regurgitation group (17 patients) and an aortic valve stenosis group (112 patients).ResultsThe incidence of valve in valve was higher in the pure native aortic valve regurgitation group (47.0% vs. 16.1%, P<0.01). There was no statistical difference between the two groups in conversion to surgery, intraoperative use of extracorporeal circulation, intraoperative left ventricular rupture, postoperative use of extracorporeal membrane oxygenation (ECMO), peripheral vascular complications, disabled stroke, death, or pacemaker implantation. There was no statistical difference in the diameter of annulus (25.75±2.21 mm vs. 24.70±2.90 mm, P=0.068) or diameter of outflow tract (25.82±3.75 mm vs. 25.37±3.92 mm, P=0.514) between the pure native aortic valve regurgitation group and the aortic valve stenosis group.ConclusionTransfemoral TAVR is a feasible method for patients with pure native aortic valve regurgitation. The diameter of annulus plane, the diameter of outflow tract and the shape of outflow tract should be evaluated.
Transcatheter aortic valve replacement (TAVR) has become a common theraputic option for aortic stenosis, but the evidence for precise anatomy for TAVR is accumulating. This paper presents the case of an 71-year-old female patient who had an extremely high risk of coronary obstruction due to both coronary ostia lying too low. The patient underwent TAVR with the help of coronary protection successfully. During the procedure, the patient was protected with wires only for both coronaries. After deployment, angiofluoroscopy suggested that chimney stenting should be applied for left coronary. The whole procedure was unenventful and both coronaries were seen.
